Cephalon reports positive data

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NEW YORK (CBS.MW) -- Shares of Cephalon fell Wednesday, even after the company presented positive data on its sleep-fighting drug Provigil that may eventually lead to its approval for other uses outside of narcolepsy.

Researchers reported results of studies of Provigil tablets in specific settings that required sustained performance and alertness, including shift and military work. Three separate research groups presented data that showed Provigil consistently improved both performance and alertness in sleep-deprived subjects, the company said.

The data were presented Tuesday at the 14th Annual Meeting of the Associated Professional Sleep Societies in Las Vegas.

Shares were down 5 1/16 to 58 1/16.

Provigil was approved by the U.S. Food and Drug Administration in 1998 as a once-a-day treatment to improve wakefulness in patients who experience excessive daytime sleepiness associated with narcolepsy.

Narcolepsy is a chronic sleep disorder that?s characterized by excessive and overwhelming daytime sleepiness that leads to a person's falling asleep at inappropriate times and places, according to InteliHealth. Daytime sleep attacks may occur without warning and may be irresistible, and they can occur repeatedly during the day.

Dr. Charles Czeisler, co-director of the division of Sleep Medicine at Harvard Medical School, presented the results of a trial that studied Provigil in a simulated shift work environment for four consecutive nights.

Shift workers typically work non-traditional hours, usually between 10:00 p.m. and 6:00 a.m., and often have problems with alertness and performance, which are also characteristic signs of sleep deprivation, Cephalon
CEPH
said. Data showed that a 200 mg dose of Provigil improved alertness and performance and did not impair or disrupt subsequent daytime sleep opportunities. The most commonly reported side effects were nausea and headache, the company said.

Dr. Nancy Wesensten, of the department of Neurobiology and Behavior at the Walter Reed Army Institute of Research in Washington D.C., presented data on the effect of Provigil on cognitive performance during prolonged sleep deprivation. The study compared three doses of Provigil to a high dose of caffeine and to a placebo in 50 subjects who were sleep-deprived. Performance and alertness were assessed over a 54-hour period of continuous work, with no opportunity to sleep.

Results from the study demonstrated that 200 mg and 400 mg of Provigil improved alertness and performance. The investigator concluded that 400 mg of Provigil was as consistently effective as a 600 mg dose of caffeine, but caused fewer side effects, such as disorientation and vomiting.

In another military performance study, Dr. John Caldwell of the U.S. Army Aeromedical Research Laboratory at Fort Rucker, Alabama, presented data from a study of six helicopter pilots using a flight simulator. The helicopter pilots were exposed to two 40-hour periods of continuous wakefulness separated by one night of recovery sleep. Results of the study demonstrated that pilots receiving three 200 mg doses of Provigil scored better on tests of performance, physiological arousal and mood than they did while on placebo. The most commonly reported side effects in the study were jitteriness, nausea and vertigo.

Based on the results of these studies, Cephalon plans to initiate additional trials in shift work

?We are pleased that these studies support the hypothesis that Provigil can improve alertness and performance in subjects who are sleep deprived,'' Dr. Earl Henry, senior vice president, clinical research and regulatory affairs at Cephalon, said in a statement.

Henry said the company is planning to initiate additional clinical studies with Provigil in shift work and sleep-deprived subjects later this year. ?We expect that these studies, and other completed and on-going studies, will support our plans to file an application to expand the approved indication for Provigil,? Henry said.

SG Cowen analyst Eric Schmidt said that Cephalon is on track to meet his second-quarter sales forecast of $13.5 million for Provigil sales. He sees sales of the drug of $59 million in the 2000 fiscal year, rising to $110 million in 2001 and $160 million the year after. Schmidt said he expects the company to turn profitable in the second half of 2001, based on sales of Provigil.

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